Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | RIANEN I125 |
Generic Name | KIT, ASSAY, ESTROGEN RECEPTOR |
Regulation Number | 864.1860 |
Applicant | DUPONT LEGAL 4417 LANCASTER PIKE WILMINGTON, DE 19805 |
PMA Number | P800061 |
Supplement Number | S001 |
Date Received | 10/22/1980 |
Decision Date | 06/02/1981 |
Withdrawal Date
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02/07/2012 |
Product Code |
LPJ |
Advisory Committee |
Clinical Chemistry |
Expedited Review Granted? | No |
Combination Product | No |
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